Auditing Takes Center Stage in FSMA

Under the FSMA Accredited Third-Party Certification Rule, the FDA now has the option of contracting with third-party certification bodies that meet its accreditation criteria to conduct audits on its behalf. These audits could either be regulatory audits of foreign facilities or consultative audits that assist companies in understanding gaps in practice that need to be addressed to come into compliance with the pertinent FSMA regulations. This is an important development, giving FDA the capacity now to cover more of the regulated industry, particularly foreign suppliers, and enabling industry to utilize more tools to identify gaps in their practices before they undergo a regulatory audit or inspection.

Additionally, foreign suppliers may seek certification from accredited third-party certification bodies to establish their eligibility for participation in the Voluntary Qualified Importer Program, which offers expedited review and entry of food into the U.S. Third-party certification bodies and auditors may also be contracted to conduct assessments against certification criteria for cases in which high-risk food categories are offered for import. If the FDA has reason to be concerned about the safety of products from certain countries, territories, or regions with increased food safety risks, it now has the discretion under FSMA to require import certification as a condition of entry. Though this new authority has not been activated by FDA yet, it could be at any time, and could require the use of third-party audits or third-party certification bodies to conduct assessments per FDA’s specific requirements.

Expectations

The passage and implementation of FSMA will have a significant influence on the use of audits and auditors. Private food safety audit schemes will likely modify their requirements to incorporate FSMA provisions. This has already begun with some GFSI benchmarked schemes, which have created tools to help stakeholders understand the gaps between their provisions and FSMA requirements, and understand how to use their provisions to achieve compliance with the FSMA regulations.

Given FDA’s requirement to conduct audits in some cases for supply chain verification and its identification of audits as an appropriate supply chain verification activity, it would not be surprising to see the use of third-party audit schemes increase in the coming years. Moreover, FDA’s ability to use third-party certification bodies and auditors to assess compliance of foreign suppliers and approval of accredited third-party certification bodies to conduct consultative audits for industry will probably result in growth of this practice and the auditing industry. While this is a positive development, it likely will not be without growing pains and complications, as third-party certification bodies and auditors, tasked with maintaining their objectivity and independence, interface with both FDA and its regulated industry. In addition, FDA’s focus on ensuring that certain activities are performed by “qualified individuals,” and that auditing is conducted by “qualified auditors,” will undoubtedly increase focus on ensuring auditor competence.

FSMA underscores the role and importance of audits and “qualified auditors” in a functional preventive controls system. It remains to be seen how this will transform the private food safety audit industry; however, it is safe to say it will likely raise the bar for private auditing performance, given industry and FDA’s reliance on this work for assessing and ensuring regulatory compliance.

Dr. Crawford, senior technical trainer for food safety at SCS Global Services, has over 14 years of experience in developing, implementing, and evaluating food safety systems across the supply chain. She also served as a food microbiology and produce safety expert for the development of FDA’s FSMA regulations, policies, and programs. Reach her at [email protected].